Evidence-Based Practice Research Program, Mayo Clinic, Rochester, Minn; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn.
Division of General Internal Medicine, Mayo Clinic, Rochester, Minn.
J Vasc Surg. 2019 Jun;69(6S):126S-136S. doi: 10.1016/j.jvs.2018.01.071. Epub 2019 May 28.
The optimal strategy for revascularization in infrainguinal chronic limb-threatening ischemia (CLTI) remains debatable. Comparative trials are scarce, and daily decisions are often made using anecdotal or low-quality evidence.
We searched multiple databases through May 7, 2017, for prospective studies with at least 1-year follow-up that evaluated patient-relevant outcomes of infrainguinal revascularization procedures in adults with CLTI. Independent pairs of reviewers selected articles and extracted data. Random-effects meta-analysis was used to pool outcomes across studies.
We included 44 studies that enrolled 8602 patients. Periprocedural outcomes (mortality, amputation, major adverse cardiac events) were similar across treatment modalities. Overall, patients with infrapopliteal disease had higher patency rates of great saphenous vein graft at 1 and 2 years (primary: 87%, 78%; secondary: 94%, 87%, respectively) compared with all other interventions. Prosthetic bypass outcomes were notably inferior to vein bypass in terms of amputation and patency outcomes, especially for below knee targets at 2 years and beyond. Drug-eluting stents demonstrated improved patency over bare-metal stents in infrapopliteal arteries (primary patency: 73% vs 50% at 1 year), and was at least comparable to balloon angioplasty (66% primary patency). Survival, major amputation, and amputation-free survival at 2 years were broadly similar between endovascular interventions and vein bypass, with prosthetic bypass having higher rates of limb loss. Overall, the included studies were at moderate to high risk of bias and the quality of evidence was low.
There are major limitations in the current state of evidence guiding treatment decisions in CLTI, particularly for severe anatomic patterns of disease treated via endovascular means. Periprocedural (30-day) mortality, amputation, and major adverse cardiac events are broadly similar across modalities. Patency rates are highest for saphenous vein bypass, whereas both patency and limb salvage are markedly inferior for prosthetic grafting to below the knee targets. Among endovascular interventions, percutaneous transluminal angioplasty and drug-eluting stents appear comparable for focal infrapopliteal disease, although no studies included long segment tibial lesions. Heterogeneity in patient risk, severity of limb threat, and anatomy treated renders direct comparison of outcomes from the current literature challenging. Future studies should incorporate both limb severity and anatomic staging to best guide clinical decision making in CLTI.
在下肢慢性肢体威胁性缺血（CLTI）的血运重建中，最佳策略仍存在争议。比较性试验较少，日常决策通常是基于传闻或低质量的证据做出的。
我们通过 2017 年 5 月 7 日搜索了多个数据库，以寻找至少有 1 年随访的前瞻性研究，这些研究评估了 CLTI 成人下肢血运重建术患者相关结局。独立的审查员对文章进行选择和数据提取。使用随机效应荟萃分析汇总研究结果。
我们纳入了 44 项研究，共纳入 8602 例患者。围手术期结局（死亡率、截肢率、主要不良心脏事件）在治疗方式之间相似。总体而言，与所有其他干预措施相比，有腘下病变的患者大隐静脉移植物通畅率在 1 年和 2 年时更高（一级通畅率：87%，78%；二级通畅率：94%，87%）。人造旁路的结果在截肢和通畅率方面明显劣于静脉旁路，尤其是在 2 年及以后的膝下靶标。药物洗脱支架在腘下动脉中的通畅率优于裸金属支架（1 年时一级通畅率为 73%，而 50%），与球囊血管成形术至少相当（66%一级通畅率）。2 年时的生存率、主要截肢率和无截肢生存率在血管内介入治疗和静脉旁路之间大致相似，但人造旁路的肢体丢失率更高。总体而言，纳入的研究存在中度至高度偏倚风险，证据质量较低。
在指导 CLTI 治疗决策的当前证据状态中存在重大局限性，特别是对于通过血管内手段治疗的严重解剖病变模式。围手术期（30 天）死亡率、截肢率和主要不良心脏事件在各种方式之间大致相似。大隐静脉旁路的通畅率最高，而人造移植物在膝下靶标以下的通畅率和肢体存活率明显较差。在血管内介入治疗中，经皮腔内血管成形术和药物洗脱支架似乎对腘下病变的疗效相当，尽管没有研究纳入长段胫骨病变。患者风险、肢体威胁严重程度和治疗的解剖分期的差异使得很难直接比较当前文献中的结果。未来的研究应同时考虑肢体严重程度和解剖分期，以最好地指导 CLTI 的临床决策。
